The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, John Geigert

Автор: Jos? das Neves; Bruno Sarmento
Название: Mucosal Delivery of Biopharmaceuticals
ISBN: 1461495237 ISBN-13(EAN): 9781461495239
Издательство: Springer
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Цена: 27950.00 р.
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Описание: Mucosal Delivery of Biopharmaceuticals

Автор: G. Walsh; B. Murphy
Название: Biopharmaceuticals, an Industrial Perspective
ISBN: 9048152372 ISBN-13(EAN): 9789048152377
Издательство: Springer
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Цена: 36570.00 р.
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Описание: This book provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary, rendering it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry, or medicine.

Автор: Beck Alain
Название: Glycosylation Engineering of Biopharmaceuticals
ISBN: 1627033262 ISBN-13(EAN): 9781627033268
Издательство: Springer
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Описание: This Methods in Molecular Biology(TM) book offers protocols for glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. Covers glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complex characterization and PK/PD assays.

Автор: Alain Beck
Название: Glycosylation Engineering of Biopharmaceuticals
ISBN: 1493962663 ISBN-13(EAN): 9781493962662
Издательство: Springer
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Цена: 16769.00 р.
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Описание: Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of monoclonal antibodies (mAbs) and other proteins. In Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols, experts in the field provide readers with production and characterization protocols of glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. The volume is divided in four complementary parts dealing with glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complexes characterization, and PK/PD assays for therapeutic antibodies. Written in the highly successful Methods in Molecular Biology™ series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols serves as an ideal guide for scientists striving to push forward the exciting field of engineered biopharmaceuticals.

Автор: Jos? das Neves; Bruno Sarmento
Название: Mucosal Delivery of Biopharmaceuticals
ISBN: 1489978380 ISBN-13(EAN): 9781489978387
Издательство: Springer
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Цена: 23508.00 р.
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Описание:

.-1. Concepts in Mucosal Immunity and Mucosal Vaccines
.-Simona Gallorini, Derek T. O'Hagan, Barbara C. Baudner

.-2. Mucoadhesion and Characterization of Mucoadhesive Properties
.-Tao Yu, Gavin P. Andrews, David S. Jones

.-3. Mucus as a Barrier for Biopharmaceuticals and Drug Delivery Systems
.-Hongbo Zhang, Mohammed-Ali Shahbazi, Patrick Almeida, Hйlder A. Santos

.-4. Epithelial Permeation and Absorption Mechanisms of Biopharmaceuticals
.-Hanne M rck Nielsen

.-5. Oral Delivery of Biopharmaceuticals
.-Catarina Oliveira Silva, Bruno Sarmento, Catarina Pinto Reis

.-6. Buccal Delivery of Biopharmaceuticals: Vaccines and Allergens
.-Sevda Şenel, Merve Cansız, Michael J. Rathbone

.-7. Pulmonary Delivery of Biopharmaceuticals
.-Fernanda Andrade, Catarina Moura, Bruno Sarmento

.-8. Nasal Delivery of Biopharmaceuticals
.-Eiji Yuba, Kenji Kono

.-9. Ocular Delivery of Biopharmaceuticals
.-Holly Lorentz, Heather Sheardown

.-10. Vaginal Delivery of Biopharmaceuticals
.-Josй das Neves

.-11. Nanoparticles-in-Microsphere Oral Delivery Systems (NiMOS) for Nucleic Acid Therapy in the Gastrointestinal Tract
.-Shardool Jain, Mansoor Amiji

.-12. Bacteria-Based Vectors for Oral Gene Therapy
.-Yong Bai, Rachael Burchfield, Sangwei Lu, Fenyong Liu

.-13. Self-Assembled Polysaccharide Nanogels for Nasal Delivery of Biopharmaceuticals
.-Tomonori Nochi, Yoshikazu Yuki, Kazunari Akiyoshi, Hiroshi Kiyono

.-14. Pheroid(TM) Vesicles and Microsponges for Nasal Delivery of Biopharmaceuticals
.-Lissinda H. du Plessis, Awie F. Kotzй

.-15. Delivery Strategies for Developing siRNA-Based Vaginal Microbicides
.-Joseph A Katakowski, Deborah Palliser

.-16. Delivery Strategies for Developing Vaginal DNA Vaccine Combining Cell-Penetrating Peptides and Jet Injection
.-Takanori Kanazawa, Hiroaki Okada

.-17. Vaccine Delivery Systems for Veterinary Immunization
.-Juan M. Irache, Ana I. Camacho, Carlos Gamazo

.-18. Eligen(R) Technology for Oral Delivery of Proteins and Peptides
.-Sunita Prem Victor, Willi Paul, and Chandra P. Sharma

.-19. The RapidMist(TM) System for Buccal Delivery of Insulin
.-Meena Bansal, Sanjay Bansal, Rachna Kumria

.-20. The Pharmaceutical Development of rhDNase (Dornase Alpha) for the Treatment of Cystic Fibrosis
.-Steven J. Shire, Thomas M. Scherer

.-21. Development of the Exubera(R) Insulin Pulmonary Delivery System
.-Cynthia L. Stevenson, David Bennett

.-22. Technosphere(R) An Inhalation System for Pulmonary Delivery of Biopharmaceuticals
.-Antуnio J. Almeida, Ana Grenha

.-23. ChiSys(R) as a Chitosan-Based Delivery Platform for Nasal Vaccination
.-Peter Watts, Alan Smith, Michael Hinchcliffe

.-24. Development of a Cationic Nanoemulsion Platform (Novasorb(R)) for Ocular Delivery
.-Frйdйric Lallemand, Philippe Daull, Jean-Sйbastien Garrigue

.-25. Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology and Clinical Aspects
.-Karen Brigitta Goetz, Yuansheng Sun, Katrin Fйchir, Evelyne Kretzschmar, Isabel Buettel